miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment
MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment
1 other identifier
observational
100
1 country
1
Brief Summary
MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 28, 2019
August 1, 2019
3.9 years
December 12, 2018
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response
Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Resistant group was defined ad progression disease (PD) and/or stable disease (SD).Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient.
Every 2 cycles, up to surgery (each cycle is 21 days)
Study Arms (2)
Sensitive
Sensitive group was defined ad complete response (CR) and/or partial response (PR). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.
Resistant
Resistant group was defined ad progression disease (PD) and/or stable disease (SD). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.
Interventions
The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.
Eligibility Criteria
Female, Breast Cancer, \>18 years,\<75 years, early stage breast cancer patients, with Stage II-III disease
You may qualify if:
- Early breast cancer patients;
- Stage II-III disease;
- sign informed consent form;
- receive neoadjuvant treatment;
- Age between 18-75.
You may not qualify if:
- Women during pregnancy;
- Metastasis patients or stage IV breast cancer patients;
- Male breast cancer patients;
- Inflammatory breast cancer patients;
- Patients with neoadjuvant endocrine treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui Yiminlead
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Related Publications (4)
Li Q, Liu M, Ma F, Luo Y, Cai R, Wang L, Xu N, Xu B. Circulating miR-19a and miR-205 in serum may predict the sensitivity of luminal A subtype of breast cancer patients to neoadjuvant chemotherapy with epirubicin plus paclitaxel. PLoS One. 2014 Aug 19;9(8):e104870. doi: 10.1371/journal.pone.0104870. eCollection 2014.
PMID: 25137071BACKGROUNDWang H, Tan G, Dong L, Cheng L, Li K, Wang Z, Luo H. Circulating MiR-125b as a marker predicting chemoresistance in breast cancer. PLoS One. 2012;7(4):e34210. doi: 10.1371/journal.pone.0034210. Epub 2012 Apr 16.
PMID: 22523546BACKGROUNDZhao R, Wu J, Jia W, Gong C, Yu F, Ren Z, Chen K, He J, Su F. Plasma miR-221 as a predictive biomarker for chemoresistance in breast cancer patients who previously received neoadjuvant chemotherapy. Onkologie. 2011;34(12):675-80. doi: 10.1159/000334552. Epub 2011 Nov 23.
PMID: 22156446BACKGROUNDZhu W, Liu M, Fan Y, Ma F, Xu N, Xu B. Dynamics of circulating microRNAs as a novel indicator of clinical response to neoadjuvant chemotherapy in breast cancer. Cancer Med. 2018 Sep;7(9):4420-4433. doi: 10.1002/cam4.1723. Epub 2018 Aug 11.
PMID: 30099860BACKGROUND
Biospecimen
For each patient, 4 mL of peripheral blood will be collected as per predesigned schedule. Within 4 hours of blood drawl, samples will be centrifuged at 1500g for 10min at 4℃ to separate the plasma supernatant. The plasma and the blood cell will be aliquoted and stored at -80℃ until analysis, respectively.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yimin Cui, Ph.D & M.D
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of pharmacy, M.D & Ph.D
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 19, 2018
Study Start
November 1, 2015
Primary Completion
September 30, 2019
Study Completion
December 31, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
We would not like to share individual participant data (IPD) but share the result after statistical analysis. If IPD was needed, please contact us by e-mail.